Stapler apparatus and methods for use

ABSTRACT

Apparatus and methods are provided for performing a medical procedure, such as a laparoscopic appendectomy using a stapler apparatus including a reusable handle portion including a shaft include proximal and distal ends, a disposable end effector attached to the distal end of the shaft of the reusable handle carrying one or more staples. For example, the end effector may include first and second jaws movable relative to one another between open and closed positions, the first jaw carrying a cartridge which includes the one or more staples. A Doppler sensor, a cutting element, and, optionally, a thermal element are also provided on the end effector. The end effector is introduced into a patient&#39;s body, tissue is positioned/locked between the jaws, and a plurality of staples are deployed into the tissue. The Doppler sensor is used to confirm that blood flow has discontinued in the stapled tissue, and the cutting element is actuated to sever the stapled tissue.

RELATED APPLICATION DATA

The present application claims benefit of co-pending U.S. provisionalapplication Ser. No. 62/947,903, filed Dec. 13, 2019, the entiredisclosure of which is expressly incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates generally to apparatus, systems, andmethods for performing medical procedures, and, more particularly, tostapler apparatus for performing laparoscopic or other surgery, e.g., toremove an appendix of a subject, and systems and methods for using suchapparatus.

BACKGROUND

Appendicitis is seen in approximately 5-10% of the population in theirlife time. Since 1983, laparoscopic appendix surgery is the mainstay fortreatment. In an example of conventional surgery to remove an appendix,the following steps may be performed. First, the appendix and its vesselmay be initially identified e.g., lying within a fold of tissue calledthe mesoappendix. A window or surgical field may be created within thesubject's body, and a stapler apparatus is then used, e.g., to initiallystaple and divide the structure closest to the operator, and then tostaple and divide the remaining structure.

For example, FIG. 1 shows exemplary anatomy of an appendix, which mayhave one of a variety of orientations relative to the intestine, mostcommonly retrocecal (64%) or pelvic (32%), although less commonpositions may also be encountered, as shown. An appendicular artery andother blood vessels (not shown) deliver blood to the appendix, whoselocation relative to the intestine may also vary depending on theorientation of the appendix. The appendix and artery may be separated byfat and/or other tissue. Thus, during a procedure, upon accessing theabdominal cavity, the operator must identify the relative locations ofthe appendix and vessels before removing the appendix. For example,after identification, the operator may identify the intra-operativemanifestation or positioning of the appendix and its vessel, i.e., toidentify whether the appendix is closer to the operator and the vesselis positioned further away or vice-versa, and then sequentially stapleand divide the closer structure, and then the more distant structure.

To perform laparoscopic or open surgery, a device may be introducedcarrying a camera that is independent from the stapler, e.g., to enablevisualization of the surgical space and anatomy from the side, e.g.,when the stapler is introduced and used to remove the appendix. Existinglaparoscopic staplers generally include a cartridge having multiple rowsof staples equally distributed on either side of a knife.

One of the most common complications from such surgery is post-operativebleeding. The bleeding is generally sub-clinical in approximately 15%,and clinical in approximately 5% patients, i.e., requiring furtherintervention. The majority of bleeding occurs from the staple line onindividual vessels or vessels within the wall of intestine. For example,“B” shaped clips may create a lumen between the tines that may allowblood or other fluid to escape. Other complication include leaking ofintestinal fluid from the intestinal lumen.

Accordingly, apparatus and methods that facilitate laparoscopic surgery,e.g., to remove an appendix would be useful.

SUMMARY

The present invention is directed to apparatus, systems, and methods forperforming medical procedures, and, more particularly, to staplerapparatus for performing surgery, such as laparoscopic surgery, e.g., toremove an appendix of a subject or to perform other intestinalprocedures, vascular surgery, lung surgery, and the like, and to systemsand methods for using such apparatus.

In accordance with an exemplary embodiment, an apparatus is provided forperforming a medical procedure that includes a shaft including aproximal end and a distal end sized for introduction into a patient'sbody; first and second jaws on the distal end of the shaft that aremovable relative to one another between open and closed positions,thereby directing first and contact surfaces of the first and secondjaws away from and towards one another, respectively, the first jawcarrying one or more staples deployable from the first contact surface;a Doppler radar or other sensor on one of the first and second contactsurfaces; and a handle on the proximal end of the shaft comprising afirst actuator for opening and closing the jaws, e.g., a trigger toclose the second jaw adjacent the first jaw to capture tissue betweenthe contact surfaces, a second actuator for deploying one or morestaples from the first jaw into tissue between the first and secondcontact surfaces, e.g., after locking the jaws closed using the triggeror a separate locking mechanism, and a third actuator for activating theDoppler or other sensor to detect blood flow in the tissue.

In an exemplary embodiment, the first and second jaws may be carried onan end effector removably coupled to the distal end of the shaft. Thefirst jaw may carry first and second sets of staples, e.g., each setarranged in rows adjacent one another, optionally arranged within areplaceable cartridge. A cutting element may be disposed on the distalend, e.g., movable between the first and second sets of staples, e.g.,using a fourth actuator on the handle to advance the cutting element tosever the stapled tissue. In addition or alternatively, a thermalelement or other hemostasis element may also be provided on one of thefirst and second jaws, e.g., opposite the Doppler sensor, and the handlemay include a fifth actuator for activating the hemostasis element todeliver thermal energy to the stapled tissue. Optionally, the handle mayinclude one or more additional actuators, e.g., one or more controls forpositioning and/or activating a light and/or camera carried on thedistal end of the shaft or the end effector.

In accordance with another embodiment, an end effector is provided for astapler apparatus including a shaft including a proximal end including ahandle and a distal end sized for introduction into a patient's body.The end effector may include one or more connectors for removablyconnecting the end effector to the distal end of the shaft and,optionally, a cartridge insertable into a recess of one of the jaws. Thefirst and second jaws are movable relative to one another between openand closed positions, thereby directing contact surfaces of the firstand second jaws away from and towards one another, respectively. Forexample, the first jaw may be fixed and the second jaw may be pivotallymounted to open and close relative to the first jaw, e.g., to capturetissue between the contact surfaces. One or more staples are carried bythe first jaw, e.g., in a replaceable cartridge, such that actuation ofa staple actuator on the handle deploys one or more staples from thefirst jaw into tissue between the contact surfaces and towards thesecond jaw to deform the one or more staples. Optionally, a Dopplerradar sensor and/or hemostasis element may be provided on one of thecontact surfaces to detect blood flow in the tissue.

In accordance with still another embodiment, a method is provided forperforming a surgical procedure within a patient's body that includesintroducing first and second jaws on a distal end of a shaft into aregion within the patient's body; with the jaws in an open position,placing tissue within the region between contact surfaces of the firstand second jaws; closing the jaws to engage the tissue; actuating astaple actuator to deploy one or more staples from the first jaw intothe tissue towards the second jaw to deform the one or more staples andsecure the tissue. For example, the second jaw may be closed to squeezethe tissue between the contact surfaces and, optionally, may be lockedin the closed position. The staple(s) may be then be deployed from thefirst jaw using the staple actuator such that they are directed throughthe tissue and engage anvils or shaping surfaces on the second jaw todeform tines of the staple(s). A Doppler or other sensor on one of thecontact surfaces may be activated to detect blood flow in the stapledtissue; and after confirming that blood flow has discontinued in thestapled tissue, a cutting element may be actuated to sever the stapledtissue from adjacent tissue at the region.

In accordance with yet another embodiment, a method is provided forperforming an appendectomy within a patient's body that includesintroducing first and second jaws on a distal end of a shaft into anabdominal cavity of the patient's body; placing an appendix andappendicular artery within the abdominal cavity between contact surfacesof the first and second jaws; actuating one or both of the first andsecond jaws to secure the appendix and artery between the contactsurfaces; and deploying one or more staples from the first jaw throughthe appendix and artery to staple the appendix and artery. Thereafter, aDoppler sensor on one of the contact surfaces may be activated to detectblood flow in the stapled appendix and artery, and, if blood flow isdetected, a thermal element may be activated to deliver thermal energyto stop blood flow, e.g., alternately to detect and cauterize thetissue. Once blood flow ash stooped, a cutting element may be actuatedto simultaneously sever the appendix and artery.

In accordance with another embodiment, an apparatus is provided forperforming a medical procedure that includes a shaft including aproximal end, a distal end sized for introduction into a patient's body,and a longitudinal axis extending between the proximal and distal ends;first and second jaws on the distal end of the shaft that are movablerelative to one another between open and closed positions, therebydirecting first and contact surfaces of the first and second jaws awayfrom and towards one another, respectively, the first jaw carrying firstand second sets of staples positioned on opposite sides of a cuttingelement, wherein at least some of the staples are a different size thanother staples; and a handle on the proximal end of the shaft. Forexample, each set of staples may include one to five rows of staplesaligned along the longitudinal axis, with two to fifty staples in eachrow. The staples in each set and/or each row may have different sizesdepending on the anatomy encountered. For example, the apparatus mayinclude a plurality of available cartridges, each including differentarrangements of staples, that may be selected and inserted into a cavityof the first jaw. The handle includes a first actuator for driving thestaples from the first jaw into tissue between the first and secondcontact surfaces and towards the second jaw to deform the staples; and asecond actuator for advancing the cutting element from a retractedposition to an advanced position aligned with the longitudinal axis tosever the stapled tissue.

In accordance with yet another embodiment, an end effector is providedfor a stapler apparatus including a shaft comprising a proximal endincluding a handle, a distal end sized for introduction into a patient'sbody, and a longitudinal axis extending between the proximal and distalends. The end effector may include one or more connectors for removablyconnecting the end effector to the distal end of the shaft; first andsecond jaws that are movable relative to one another between open andclosed positions using a first actuator on the handle, thereby directingfirst and contact surfaces of the first and second jaws away from andtowards one another, respectively; and a cartridge carried by the firstjaw comprising first and second sets of staples arranged in rows onopposite sides of a cutting element such that actuation of a secondactuator on the handle deploys the staples into tissue between the firstand second contact surfaces and drives the staples against the secondjaw to deform the one or more staples, wherein at least some of thestaples are a different size than other staples.

In accordance with still another embodiment, a staple is provided fordelivery into tissue that includes a substantially straight base elementincluding first and second ends; a first tine extending from the firstend substantially perpendicular to the base, the first tine having afirst length and including one or more notches adjacent a tip of thefirst tine; and a second tine extending from the second endsubstantially perpendicular to the base to a second tip, the second tinehaving a second length longer than the first length and longer than thelength of the straight base such that, when the second tine is bentadjacent the base, the second tip of the second tine is engaged in theone or more notches located on the first tine.

In accordance with another embodiment, a port is provided forintroducing one or more instruments into a patient's body that includesan elongate tubular member comprising a proximal end, a distal end sizedfor introduction into a patient's body, and a lumen extending betweenthe proximal and distal ends, thereby defining a longitudinal axis therebetween; a display; and one or more deployment arms on the tubularmember adjacent the distal end carrying an imaging device, eachdeployment arm comprising a first end pivotably coupled to the tubularmember and a second free end that is movable from a retracted positionwherein the second end is aligned with a wall of the tubular member anda deployed position wherein the second end moves outwardly relative tothe longitudinal axis for presenting images on the display.

In accordance with still another embodiment, a port is provided forintroducing one or more instruments into a patient's body that includesan elongate tubular member comprising a proximal end, a distal end sizedfor introduction into a patient's body, and a primary lumen extendingbetween the proximal and distal ends for receiving an instrumenttherethrough, and a plurality of secondary lumens positioned around theprimary lumen and extending between the proximal and distal ends; and avideo module. The video module may include a hub; a display; and aplurality of elongate imaging elements mounted to the hub and sized forintroduction simultaneously into respective secondary lumens of thetubular member such that distal tips of the imaging elements arepositioned adjacent the distal end of the tubular member for acquiringimages beyond the distal end.

Other aspects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate exemplary embodiments of the invention, inwhich:

FIG. 1 is a detail showing exemplary anatomy of an appendix, which mayhave a variety of orientations relative to the intestine.

FIG. 2A is a side view of an exemplary embodiment of a stapler apparatusincluding a reusable portion including a shaft extending from a handleand a disposable end effector coupled to the shaft.

FIGS. 2B and 2C are side and perspective views, respectively, of theapparatus of FIG. 2A with a display on the reusable portion.

FIGS. 3A and 3B are perspective and side views, respectively, of anexemplary embodiment of an end effector that may be coupled to the shaftof the apparatus of FIG. 2A, the end effector including a first jawcarrying a plurality of staples within a cartridge and a second jawpivotable relative to the first jaw between an open position (FIG. 3A)and a closed position (FIG. 3B).

FIG. 3C is a cross-sectional view of the end effector of FIGS. 3A and 3Bwith the jaws spaced apart.

FIG. 4A is a top view of the first (bottom) jaw of the end effectorshown in FIGS. 3A and 3B with a cartridge carrying staples received in acavity of the jaw.

FIGS. 4B and 4C are top views of alternative embodiments of first jawsand cartridges that may be provided that include different size staplesand receptacles.

FIGS. 5A-5C are cross-sectional views showing alternative embodiments ofjaws and cartridges including a Doppler sensor and/or thermal element atdifferent locations on the jaws.

FIGS. 6A and 6B are perspective views of an exemplary embodiment of anaccess port including a deployable imaging system carried on deploymentarms in retracted and deployed configurations, respectively.

FIG. 6C is a perspective view of the access port of FIGS. 6A and 6B witha portion of the tubular shaft removed to show details of the deploymentarms of the imaging system.

FIGS. 6D and 6E are top views of the access port of FIGS. 6A and 6B,respectively, with a portion of the tubular shaft removed to showdetails of the deployment arms of the imaging system.

FIGS. 7A and 7B are perspective views of an exemplary embodiment of astaple or clip that may be delivered using the stapler apparatus herein.

FIG. 7C is a side view of the staple of FIGS. 7A and 7B.

FIG. 7D is a side view of the staple of FIGS. 7A and 7B, showing a firsttine of the staple being deformed and engaged with a second tine of thestaple.

FIGS. 8A-8E are side views of alternative embodiments of staples orclips that may be delivered using the stapler apparatus herein.

FIGS. 9A and 9B are perspective and side views, respectively, of anotherexemplary embodiment of an access port including a disposable tubularmember and a reusable video module that may be coupled to the tubularmember.

FIG. 9C is a perspective view of the access port of FIGS. 9A and 9B withimaging elements of the video module activated.

FIG. 10 is a perspective view of the tubular member of FIGS. 9A-9C.

FIG. 11 is a perspective view of a video module that includes elongateimaging sleeves receivable in corresponding lumens of the tubularmember.

FIGS. 12A and 12B are details of the distal end of the tubular member ofFIG. 10 before and after inserting the imaging sleeves of the videomodule into secondary lumens of the tubular member.

FIG. 13A is a perspective view of the access port of FIGS. 9A-9C with astapler apparatus inserted through a primary lumen of the tubularmember.

FIG. 13B is a detail of a distal end of the access port of FIG. 13Ashowing an end effector of the stapler apparatus.

FIG. 14 is a perspective view of another embodiment of a staplerapparatus including an integral video module including a display and aplurality of imaging sleeves extending from a handle of the apparatusand insertable into an end effector (not shown).

FIGS. 15A-15D are details showing a wedge actuation mechanism fordeploying a staple from a cartridge received in a jaw of an endeffector.

FIG. 16 is a flowchart showing an exemplary method for using theapparatus herein to perform an appendectomy.

FIG. 17 is a flowchart showing an exemplary method for using an accessport and stapler to perform a surgical procedure.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Before the exemplary embodiments are described, it is to be understoodthat the invention is not limited to particular embodiments described,as such may, of course, vary. It is also to be understood that theterminology used herein is for the purpose of describing particularembodiments only, and is not intended to be limiting, since the scope ofthe present invention will be limited only by the appended claims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the invention. The upper and lower limits of these smaller rangesmay independently be included or excluded in the range, and each rangewhere either, neither or both limits are included in the smaller rangesis also encompassed within the invention, subject to any specificallyexcluded limit in the stated range. Where the stated range includes oneor both of the limits, ranges excluding either or both of those includedlimits are also included.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the present invention, some potential andexemplary methods and materials are now described.

It must be noted that as used herein and in the appended claims, thesingular forms “a,” “an,” and “the” include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “acompound” includes a plurality of such compounds and reference to “thepolymer” includes reference to one or more polymers and equivalentsthereof known to those skilled in the art, and so forth.

Turning to the drawings, FIG. 2A shows an exemplary embodiment of astapler apparatus 8 that may be used during a medical procedure, e.g.,during laparoscopic surgery to remove a patient's appendix (not shown).Generally, the apparatus 8 includes a reusable shaft/handle portion orhandpiece 10 including a shaft 20 and a handle 30, and a disposable,single-use portion or end effector 40, e.g., configured to receive asingle-use cartridge (not shown), which may be removably coupled to theshaft 20 before or during a procedure, as described further below.Alternatively, at least some of the components of the end effector 40may be permanently incorporated into the reusable portion 10, e.g., suchthat the entire apparatus 8 may be single-use or may be cleaned betweenprocedures and reused.

As shown, the shaft 20 is an elongate member, e.g., a substantiallyrigid tubular body, including a proximal end 22 and a distal end 24,defining a longitudinal axis 26 extending there between. The shaft 20may include one or more lumens or passages (not shown) extending betweenthe proximal and distal ends 22, 24, e.g., for receiving actuatorelements, wires, and/or other components, as described elsewhere herein.At least the distal end 24 of the shaft 20 is sized for introductioninto a patient's body, e.g., having a diameter sufficiently small enoughto be received through a port or cannula to allow introduction into alaparoscopic surgical space within a patient's body.

Optionally, at least a portion of the shaft 20 may be malleable, e.g.,such that at least a distal region of the shaft 20 may be deformed intoa desired shape outside the patient's body, which the shaft 20 maymaintain during introduction. Alternatively, at least a distal region ofthe shaft 20 and/or the end effector 40 may be flexible, e.g., forintroduction into body passages, such as blood vessels, GI passages, andthe like, such that the distal region follows the passages duringintroduction. Optionally, in this alternative, the shaft 20 may includeone or more steering wires or other elements therein (not shown) thatmay be actuated to change the shape of the shaft 20, e.g., to facilitateintroduction into a desired location and/or manipulation within thepatient's body.

The handle 30 may include a handgrip 32, e.g., shaped and/or otherwiseconfigured to facilitate holding and/or manipulating the apparatus 8during use. In addition, the handle 30 may include one or moreactuators, e.g., for operating mechanical and/or electrical componentson the stapler assembly 40. For example, a trigger or other jaw actuator34 may be provided, e.g., adjacent the handgrip 32, that may be pulledor otherwise actuated to jaws 46, 47 and a separate actuator (not shown)may be provided to subsequently deploy one or more staples (not shown)from the stapler assembly 40. For example, the trigger 34 may be pulledto close the second jaw 48 immediately adjacent the first jaw 46 toengage tissue between contact surfaces 46 a, 48 a, e.g., as describedfurther elsewhere herein. Optionally, the trigger 34 may include aratchet mechanism to allow the second jaw 48 to move towards the firstjaw 46 while preventing opening, e.g., to squeeze tissue between thejaws 46, 48, e.g., until a release mechanism is actuated. Alternatively,a separate locking mechanism may be provided on the handle 30, which maybe selectively activated to lock and release the second jaw 48, asdescribed elsewhere herein, In addition or alternatively, several otheractuators may be included on the handle 30 or shaft 20 10 to achieveindependent actuation of various functions/parts of the end effector,such as a staple actuator that be advanced to deploy one or more staplesand/or retracted, a cutting actuator for blade actuation (forward andbackward), a Doppler sensor trigger, an electrical cautery power switch,and/or an actuator for controlling end effector orientation.

Optionally, as shown in FIGS. 2B and 2C, a display or other outputdevice 38 may be provided on the handle 30, e.g., to facilitateobserving or otherwise monitoring the procedure. For example, a camera,light, and/or other imaging device (not shown) may be provided on thestapler assembly 40 and/or the distal end 24 of the shaft 20 that may beused to acquire images of a surgical space into which the staplerassembly 40 is introduced, as described further elsewhere herein. In oneembodiment, a display 38 may be removably mounted on the handle 30,which may include one or more connectors or cables (not shown) that maybe coupled to corresponding connectors on the handle 30, which are, inturn, coupled to one or more wires extending to the imaging device onthe stapler assembly 40. Alternatively, the display 38 may bepermanently mounted to the handle 30 and one or more wires or otherelements may communicate with the imaging device. In anotheralternative, a display (not shown) may be provided that is separate fromthe apparatus 8, and the apparatus 8 may include a communicationsinterface, e.g., a wireless transmitter, that may transmit signals fromthe imaging device wirelessly, e.g., using Bluetooth or othercommunications protocols, to allow images to be presented on thedisplay.

For example, a CMOS, CCD, or other imaging element (not shown) may beprovided on the distal end 24 of the shaft 20 (or alternatively on theend effector 40) that is oriented to acquire images of the region beyondthe stapler assembly 40 and/or between jaws 46, 48 of the end effector40. One or more wires and/or optical fiber may transmit signals to thedisplay 38, which may include a processor to process the signals andpresent the images on a screen of the display 38. In addition oralternatively, one or more LEDs or other light sources may be providedon the distal end 24 of the shaft 20 (or alternatively on the endeffector 40), e.g., adjacent the imaging element to provide illuminationfor the images. For example, one or more lights may be arrangedcircumferentially on the distal end 24 of the shaft 20, such as acircular Xenon LED lamp (not shown), e.g., operating at 200-2500 W, thatmay provide dispersed illumination (due to internal reflections in thelamp) without generating thermal energy that may damage nearby tissue.Alternatively, one or more LEDs or other light sources (not shown) maybe provided in the handle 30, and light may be transmitted using lightconductive material such as optical fiber or transparent plastic toprovide illumination to the distal end 24. The handle 30 and/or display38 may include one or more controls (not shown), e.g., to turn theillumination source(s) and/or imaging element(s) off and on, as desired.Optionally, the imaging element(s) and/or illumination source(s) may bemovable relative to the end effector 40, e.g., rotated about thelongitudinal axis 26 and, if so, one or more actuators (not shown) maybe provided on the handle 30 to rotate or otherwise adjust theirposition during a procedure.

Returning to FIG. 2A, generally, the end effector 40 on the distal end24 of the shaft 20 includes first and second jaws 46, 48 carrying one ormore staples (not shown) and, optionally, one or more additionalcomponents for use during a procedure. For example, as shown in FIGS.3A-3C, the end effector 40 may include a removable cartridge 50receivable within a recess, track, or other cavity 46 c within the firstjaw 46. The end effector 40 may also include a tubular housing 42 fromwhich the first jaw 46 extends that includes a proximal end 44 that maybe connected to the distal end 24 of the shaft 20, e.g., using one ormore detents, latches, sockets, threads and/or other connectors (notshown) on the proximal end 44 of the housing 40 and/or the distal end 24of the shaft 20. When the end effector 40 is mechanically connected tothe shaft 20 by the connector(s), additional connectors mayautomatically engage, e.g., to mechanically couple actuatable componentson the end effector 40 with actuator elements in the shaft 20 and/orelectrically couple electrical components on the end effector 40 withcorresponding wires in the shaft 20 (not shown), as will be appreciatedby those skilled in the art. For example, a wedge mechanism (not shown,see, e.g., FIGS. 15A-15D) may be provided within the housing 42 adjacentthe first jaw 46 that may be coupled to an actuator shaft (also notshown) within the shaft 20 such that actuation of a staple actuator onthe handle 30 may be activated to advance and retract the actuator shaftand wedge to deliver the staples, as described elsewhere herein.

As shown, the first jaw 46 may be integrally formed with or otherwisefixed relative to the housing 42, e.g., such that the first jaw 46remains aligned with the axis 26 of the shaft 20 during use. The secondjaw 48 may be movably mounted to the housing 42, e.g., by one or morehinges or other features (not shown) such that the second jaw 48 may bepivotable between an open position, e.g., as shown in FIG. 3A, and aclosed position, e.g., as shown in FIG. 3B. In the open position,contact surfaces 46 a, 48 a of the jaws 46, 48 may be spaced apart fromone another, e.g., to allow a tissue structure to be positioned betweenthe jaws 46, 48, e.g., on the first contact surface 46 a, while in theclosed position, the contact surfaces 461, 48 b may be immediatelyadjacent one another, e.g., substantially parallel to one another, asshown in FIG. 3B. For example, in the closed position, the contactsurfaces 46 a, 48 a may have sufficient clearance between them tosqueeze, secure, and/or otherwise engage tissue positioned between thejaws 46, 48.

The jaws 46, 48 may be biased to one of the open and closed positions ormay be actuatable between the open and closed positions. For example,the jaws 46, 48 may be provided initially in a closed position, e.g., tofacilitate introduction into a patient's body, whereupon a lock or othermechanism may be released, whereupon the second jaw 48 may automaticallymove to the open position, and the actuator 34 on the handle 30 maybecome active to deploy staples and/or close the second jaw 48, asdescribed further elsewhere herein. Alternatively, the trigger 34 on thehandle 30 may be pulled or released to close and open the second jaw 48without deploying staples to facilitate introduction and/or manipulationof the cartridge 40, e.g., until a switch or other control is actuatedto activate deployment of the staples. A locking mechanism, e.g., aratchet or other lock (not shown), may be provided to prevent the secondjaw 48 from opening until released.

With particular reference to FIG. 3A, the first jaw 46 may receive adisposable cartridge 50 which may be received in cavity 46 c of thefirst the jaw 46 such that an exposed surface 50 a of the cartridge 50defines the first contact surface 46 a. The cartridge 50 may carry aplurality of staples (not shown), e.g., in arranged in a plurality ofrows aligned with the axis 26 of the shaft 20. For example, in theembodiment shown, the contact surface 50 a of the cartridge 50 includesrecesses or receptacles 52 arranged in three rows 52 a, 52 b, 52 c fromwhich staples may be deployed simultaneously and/or in rapid succession.

Optionally, the cartridge 50 or first jaw 46 may include a thermalelement 56 on the first surface 46 a adjacent the rows of staples. Forexample, the cartridge 50 may include sets of staples disposed onopposite sides of the thermal element 56, e.g., with the sets alignedwith the axis 26 of the shaft 20. Alternatively, as shown in FIGS.5A-5C, the thermal element may be omitted from the jaws/cartridge, ifdesired. If the staples are carried by a cartridge 50 that is removablefrom the first jaw 46, the thermal element 56 may be mounted on anexposed surface of the cartridge 50, e.g., if the cartridge 50 providethe first contact surface 46 a. Alternatively, the thermal element 56may be permanently mounted on the first jaw 46 and the cartridge 50 maydefine the portions of the first contact surface 46 a on either side ofthe thermal element 56 (not shown).

In the example shown in FIGS. 3A and 4A, a first row or set of staplereceptacles 52 a may be located on the right side of the thermal element56 (from the perspective of a user holding the handle 30 of theapparatus 8), and second and third rows or sets of staple receptacles 52b, 52 c may be located on the left side of the thermal element 56. Forexample, in this configuration, the first set of staples may bedelivered into the appendix being removed, while the second set ofstaples may be delivered into the intestine and remain within thepatient's body after the appendix is removed. Alternatively, thearrangement of the receptacles 52 may be reversed if desired, e.g., withthe first set on the left and the second set on the right for approacheswhere the appendix is on the left (from the perspective of the operatorof the apparatus 8) and the intact intestine is on the right. As shown,the second set of receptacles 52 b, 52 c may include two rows of staplesthat are staggered relative to one another along the axis 26, e.g., toenhance stapling a tissue structure captured in the jaws 46, 48, asdescribed elsewhere herein.

In the embodiment shown in FIGS. 3A and 4A, the receptacles 52 havesimilar dimensions, e.g., having the same length aligned with the axis26, and the staples deployable from the receptacles 52 may have the samedimensions. Alternatively, the dimensions of the receptacles and,consequently, the staples, may be varied along each row and/or indifferent rows, as described further elsewhere herein.

For example, FIG. 4B shows an alternative embodiment of a first jaw 146(generally similar to jaw 46) except that the rows of staple receptacles152 include a first or proximal set of receptacles 153 a and a second ordistal set of receptacles 153 b that have different sizes. For example,as shown, the first two receptacles in each row 152 (in the proximal set153 a) are larger than the remaining five receptacles (in the distal set153 b). In this alternative, when the staples are deployed, the larger,proximal staples will be deployed first followed by the smaller, distalstaples, e.g., as the staple actuator (e.g., a piston and/or sledge, notshown) advances and the pushes the staples against the second jaw 48(also not shown) to deform the deployed staples.

Alternatively, as shown in FIG. 4C, different size staples may beprovided in one or more of the rows on the first jaw 246. For example,as shown, the first row may include receptacles 252 a that are largerthan the second and third rows of receptacles 252 b, 252 c.Consequently, larger staples may be deployed from the first row ofreceptacles 252 a than the others. For example, it may be desirable touse larger staples to staple an appendix while smaller staples may beused to staple the blood vessel delivering blood to the appendix. Manysmaller staples may enhance cutting off blood flow to the vessel, whichmay reduce risk of subsequent bleeding when the appendix is severed andremoved. Thus, cartridges may be provided with multiple rows on eitherthe left or right side of the cutting element 60 and with larger stapleson the other side such that an appropriate cartridge may be selected andconnected to the handpiece 30 based on the actual anatomy encountered.Optionally, one or more additional rows or sets of staples may beprovided adjacent the first, second, and/or third rows. For example,multiple sets of staples (e.g., 1-5) may be delivered into the appendixbeing removed and/or into the intestine.

Returning to FIG. 3A, the contact surface 48 a of the second jaw 48 mayinclude corresponding recesses 54, e.g., arranged in rows opposite thereceptacles 52, e.g., such that the recesses 54 are disposed directlyabove respective receptacles 52 in the closed position, e.g., to deformand/or otherwise close staples deployed from the receptacles 52, asdescribed further elsewhere herein. For example, the recesses 54 mayinclude ramped surfaces, anvils, and/or other features to deform one orboth of the tines of the staples as they are deployed, as describedfurther elsewhere herein.

Optionally, the second jaw 48 may include a Doppler radar or othersensor 58, e.g., located on the second contact surface 48 a generallyopposite the thermal element 56. For example, the Doppler sensor 58 maybe an elongate crystal element mounted on the second contact surface 56and aligned along the axis 26 (when the second jaw 48 is closed). TheDoppler sensor 58 may be configured to transmit radar signals andreceive reflections from the tissue captured between the jaws 46, 48 toidentify whether blood is flowing within the tissue, e.g., using systemsand methods known in the art.

As can be seen in FIG. 3C, the thermal element 56 and Doppler sensor 58may be located opposite one another on the first and second jaws 46, 48,respectively, between the rows of staple receptacles 52 and recesses 54.This configuration may facilitate identifying blood flow within tissuecaptured between the jaws 46, 48 and then delivering thermal energy tocauterize, ablate, or necrose the tissue, e.g., to stop subsequent bloodflow, as described elsewhere herein.

In an exemplary embodiment, the thermal element may include one or moreelectrodes, e.g., a single elongate electrode 56, e.g., extendingaxially along the first contact surface 46 a, which may be coupled to asource of electrical energy, e.g., a generator (not shown), in thehandle 30 and/or connected to the handle 30, as described furtherelsewhere herein. For example, as shown in FIG. 3C, the electrode 56 mayinclude a thermal insulator block 56 a, e.g., formed from ceramic and/orother material that is not electrically conductive, and an electrodeelement 56 b supported by the block 56 a, e.g., to prevent conductionfrom the electrode 56 to other components of the end effector 40 and/ordelivering energy to tissue that is not directly contacted by theelectrode element 56 b. In the embodiment shown, a single electrode 56may be provided for delivering radiofrequency energy in a mono-polarconfiguration to cauterize the contacted tissue, e.g., similar to Bovie®devices, as described elsewhere herein. Alternatively, multipleelectrodes may be provided that are spaced apart from one another on thefirst contact surface 46 a, which may be used to deliver RF energy in abi-polar configuration. In a further alternative, other elements may beprovided for delivering other forms of energy, e.g., laser, energy tocauterize contacted tissue.

Alternatively, the location of the thermal element 56 and Doppler sensor58 may be reversed, if desired, e.g., with the thermal element on thesecond contact surface and the Doppler sensor on the first contactsurface (not shown). In a further alternative, the thermal sensor may beomitted entirely and only a Doppler sensor 58 may be provided on one ofthe jaws, e.g., on the second jaw 48, as shown in FIG. 5A. Thus, in thisalternative, the first jaw 46′ does not include a thermal element.

In yet another alternative, the Doppler sensor may be provided at otherlocations on the second contact surface on any of these embodiments. Forexample, as shown in FIG. 5B, a Doppler sensor 58 may be provided alongone side of the second jaw 48, i.e., adjacent the third row of recesses54 c opposite the third row of staple receptacles 52 c.

In the embodiments shown in FIGS. 3C, 5A, and 5B, the Doppler sensor isoriented substantially perpendicular to the second contact surface. Inthis configuration, the centerline of the radar signals transmitted willalso be perpendicular to the second contact surface. Alternatively, itmay be desirable to orient the Doppler sensor at a non-perpendicularangle relative to the contact surface. For example, as shown in FIG. 5C,another example is shown in which a Doppler sensor 58′″ is mounted onthe second jaw 48′″ such that the sensor defines an angle relative tothe second contact surface 58 a′″. Thus, in this alternative, thecenterline of transmitted radar signals may directed diagonally from thesecond contact surface 58 a′″. Such a configuration may be useful, e.g.,to direct the radar signals towards a tissue structure of particularinterest, e.g., towards the blood vessel of the appendix, e.g., definingan angle relative to the direction of blood flow rather thanperpendicular to the direction of blood flow.

Returning to FIGS. 3A-3C, the end effector 40 may also include a bladeor other cutting element 60 slidably disposed relative to the jaws 46,48. For example, the first and second jaws 46, 48 may include respectiveslots or grooves 62, 64 aligned with the axis 26 that receive the blade60, e.g., when the blade is advanced from a retracted position (notshown), e.g., received within the housing 42 immediately adjacent thecontact surfaces 46 a, 48 a, to an advanced position, i.e., where asharpened edge 60 a of the blade 60 is advanced distally along the slots62, 64 towards distal tips 46 b, 48 b of the jaws 46, 48 (the blade 60is shown partially advanced in FIG. 3A). As can be seen in FIG. 3B, theblade 60 may extend between the contact surfaces 46 a, 48 a of the jaws46, 48, such that the edge 60 a cuts through or otherwise severs tissue(not shown) positioned between the jaws 46, 48 in the closed position,as described further elsewhere herein.

Optionally, the cartridge 40 may include one or more additionalcomponents for use during a procedure. For example, an illuminationsource and/or imaging element may be mounted on the housing 42, e.g., tofacilitate imaging and/or monitoring use of the apparatus 8 during aprocedure. In an exemplary embodiment, a CMOS, CCD, or other imagingelement and/or one or more LEDs or other light sources (not shown) maybe provided on the end effector 40, e.g., adjacent the proximal end ofthe first jaw 46 where the second jaw 48 pivots, that may be orienteddistally to acquire images of the region beyond the stapler assembly 40.For example, the field of view of the imaging element may include thefirst contact surface 46 a of the first jaw 46 such that an operator mayuse the images to position and/or orient a desired tissue structure onthe contact surface 46 a before actuating the second jaw 48 to close.

The apparatus 8 may be used to deliver staples into tissue during amedical procedure, e.g., during a laparoscopic surgical procedure, suchas an appendectomy. Initially, a surgical space may be created, e.g., byintroducing a trocar and/or cannula device (not shown) through thepatient's skin and intervening tissue to a target region, e.g., thepatient's abdominal cavity, and insufflating or otherwise opening thespace to access a desired tissue structure, such as an appendixindicated for removal.

An end effector 40 and cartridge 50 may be selected and connected to thedistal end 24 of the shaft 20 before introduction into the patient'sbody. For example, based on the anatomy encountered, the operator mayselect a cartridge 50 including a particular arrangement of staples,e.g., including uniform-size staples or different size staples, such asthose described elsewhere herein, insert the cartridge 50 into thecavity 46 c of the first jaw 46, e.g., before or after connecting theend effector 40 the shaft 20. Once the apparatus 8 is ready, the distalend 24 of the shaft 20 carrying the end effector 40 may be introducedinto the surgical space, e.g., through a cannula or other port (notshown), until the jaws 46, 48 are located the surgical space. Forexample, the surgical space may be initially accessed using a needle,trocar, and/or dilator device, e.g., punctured through the patient'sskin and intervening tissue into the abdominal cavity to approach theappendix, and a cannula may be positioned through the puncture. Gas maybe delivered through the cannula or other device to insufflate andcreate a surgical cavity or space.

The distal end 24 of the shaft 40, carrying the selected end effector 40and/or cartridge 50, may then be introduced through the cannula into thesurgical space. For example, the jaws 46, 48 may be initially locked inthe closed position to facilitate introduction through the cannula andthen may be released once located within the surgical space, whereuponthe second jaw 48 may open. Alternatively, the second jaw 48 may bebiased to open but may be manually or otherwise closed to allowinsertion through the cannula.

With the jaws 46, 48 in the open position within the surgical space,tissue within the region, e.g., the patient's appendix, may be placed onthe contact surface 46 a of the first jaw 46 and/or otherwise positionedbetween the jaws 46, 48. For example, both the appendix and theappendicular artery may be positioned between the jaws 46, 48, e.g.,with one distal to the other depending on the orientation of theappendix.

Once the tissue is positioned as desired, the trigger actuator 34 may bemanipulated to close the second jaw 48 and lock the tissue in placebetween the contact surfaces 46 a, 48 a. For example, the trigger 34 mayinclude a ratchet mechanism that allows the second jaw 48 to close whilepreventing it from reopening, or a separate locking mechanism (notshown) may activated once the second jaw 48 is closed to engage thetissue. A separate staple actuator (not shown) may then be used todeploy one or more staples from the first jaw 46 into and through thetissue and towards the second jaw 48 to deform the staples(s) and engagethe tissue.

For example, as the stapler actuator is pushed, an actuation shaft (notshown) within the shaft 20 may advance a wedge or other staple actuationelement (not shown) within the cartridge 50 or end effector 40 to begindeploying staples from the receptacles 52 out of the first contactsurface 50 a/46 a of the first jaw 46 upwardly towards the second jaw48, thereby causing one or more tines of the staples to contact thecorresponding recesses 54 in the second contact surface 48 a and deformto staple the tissue. FIGS. 15A-15D show an exemplary embodiment of awedge actuator 66 slidable within a passage 53 within a cartridge 50that includes an angled or ramped distal surface 66 a that may pushcorresponding ramped surfaces 68 a of pistons (one piston 68 shown)within respective receptacles 52 upwardly to push the correspondingstaples 90 towards the second jaw 48 (not shown in FIGS. 15A-15D), wheretines of the staples 90 are deformed within the corresponding recesses54, as described elsewhere herein. For example, the wedge 66 may becoupled to a stapler actuator shaft (not shown) that may be advanced andretracted within the passage 53, e.g., to advance the wedge 66, therebyslidably engaging the ramped surface 66 a of the wedge 66 with rampedsurfaces 68 a of the pistons 68 and directing the pistons 68 upwardly inthe respective receptacles 52, as shown in FIGS. 15B-15D. The wedge 66may then be retracted back to the position shown in FIG. 15A. It will beappreciated that other stapler mechanisms may be used instead, such asthose disclosed in U.S. Pat. Nos. 4,608,981, 4,633,874, 5,104,025,5,307,976, 5,709,680, and European Patent No. 1,157,666, the entiredisclosures of which are expressly incorporated by reference herein.

The deployment of the staples may be sequential within each set, e.g.,simultaneously delivering first staples from each of the sets 52 a-52 cat the proximal end of the first jaw 46 and, as the trigger 34 continuesto be pulled, additional staples are deployed until the desired lengthof stapling, whereupon actuation may be discontinued, which may leaveone or more staples closest to the distal tip 46 a of the first jaw 46undeployed. In this manner, the operator may control how many staplesare deployed based on the extent to which the staple actuator is pulled.Alternatively, the actuator 34 may be binary, i.e., wherein, when thetrigger 34 is initially pulled, all of the staples in the first jaw aredeployed in rapid succession.

If the apparatus 8 includes a Doppler sensor 58, e.g., on the second jaw48, the Doppler sensor 58 may be activated, e.g., using a radar actuator(not shown) on the handle 30, to detect blood flow in the stapledtissue. For example, signals from the sensor 58 may be transmitted,e.g., via one or more wires (not shown) in the shaft 20 to a processorin the handle 30, which may analyze the signals to confirm whether bloodflow has discontinued in the stapled tissue. The apparatus 8 may includean output device, e.g., an indicator light, speaker, and the like (notshown), e.g., on the handle 30 that may provide a positive indicationthat blood flow has stopped. The operator may then manipulate anotheractuator, e.g., a slider, dial, and the like (not shown) on the handle30 to advance the blade 60 to sever the stapled tissue from adjacenttissue.

If the output device indicates that blood is still flowing in thestapled tissue, additional actions may be taken to cauterize the tissueand/or stop blood flow. For example, if the apparatus 8 includes thethermal element 56, the operator may activate the thermal element todeliver thermal energy to the stapled tissue. For example, a button orswitch (not shown) on the handle 30 may be activated to deliver RFenergy from a power source coupled to the handle 30 via one or morewires (not shown) in the shaft 20 to the electrode(s) 56 a on the firstjaw 46 to cauterize the stapled tissue. Energy may be delivered untilthe output device/Doppler sensor 58 provides a confirmation that bloodflow has stopped, whereupon the blade 60 may be advanced to sever thetissue, e.g., to simultaneously sever the appendix and the appendicularartery.

Optionally, before severing the tissue, the second jaw 48 may bereleased and opened and the jaws 46, 48 repositioned relative to thestapled tissue and then closed and locked at one or more subsequentpositions, e.g., to use the Doppler sensor 58 to confirm blood flow hasstopped and/or deliver further thermal energy to cauterize the tissue.Once desired, the blade 60 may be used to sever the tissue.

The apparatus 8 may then be removed from the surgical space and theprocedure completed using conventional methods. For example, the blade60 may be retracted, and the Doppler sensor 58 and/or hemostasis element56 may be deactivated (if not already). The end effector 40 may beremoved from the patient's body with the second jaw 48 remaining lockedto remove the excised tissue.

Optionally, the procedure may be illuminated and/or monitored using anillumination source and/or imaging element on the end effector 40 and/orshaft 20, as described elsewhere herein. In addition or alternatively,other light sources and/or imaging devices may be provided to monitorthe procedure. For example, a separate endoscope may be introduced intothe surgical space, e.g., via a different cannula or port (not shown)than the cannula used to introduce the apparatus 8.

In another alternative, a cannula or access port may be provided thatincludes one or more illumination and/or imaging elements, and theapparatus 8 may be introduced using the access port. For example,turning to FIGS. 6A-6E, an exemplary embodiment of an access port 70 isshown that generally includes an elongate tubular body 72 including aproximal end 74, a distal end 76 sized for introduction into a patient'sbody, and one or more lumens or passages 78 extending at least partiallybetween the proximal and distal ends 74, 76. For example, the tubularbody 72 may include a primary lumen 78 a sized to receive one or moreinstruments therethrough that extends from an outlet in the proximal end74 to an outlet in the distal end 76, such as any of the staplerapparatus described elsewhere herein. In addition, the tubular body 72may include one or more secondary lumens (not shown), e.g., extending atleast partially from the proximal end 74 towards the distal 76, e.g.,for receiving actuator elements, wires, and/or other components, asdescribed elsewhere herein. The tubular body 72 may be substantiallyrigid or alternatively at least a portion of the tubular body 72, e.g.,a distal portion, may be malleable or flexible (not shown).

A handle or hub 80 may be provided on the proximal end 74, e.g., tofacilitate manipulation of the access port 70 during use. The hub 80 mayinclude one or more valves or seals (not shown), which may seal theprimary lumen 78 a yet facilitate inserting an instrument into theprimary lumen 78 a, e.g., providing a substantially fluid-tight sealaround the instrument. In this manner, the seal(s) may preventinsufflation gas or other fluid to escape through the primary lumen 78a, e.g., when the access port is introduced into a patient's body, asdescribed elsewhere herein.

In addition, a display or other output device 82 may be provided on thehub 80, e.g., to facilitate observing or otherwise monitoring theprocedure using one or more imaging devices on the access port 80. Forexample, a distal portion of the tubular body 72 may include a pair ofdeployable arms 84 including first ends 84 a pivotally coupled to thetubular body 72 and second or free ends 84 b that may carry one or morecameras, light sources, and/or other imaging device, as describedfurther below.

In one embodiment, the display 82 may be removably mountable on the hub80, which may include one or more connectors or cables (not shown) thatmay be coupled to corresponding connectors on the hub 80, which are, inturn, coupled to one or more wires extending to the imaging device(s) onthe arms 84. Thus, in this alternative, the display 82 may be reusableand the tubular body 72 may be disposable/single-use. Alternatively, thedisplay 82 may be permanently mounted to the hub 80 and one or morewires or other elements may communicate with the imaging device(s).Thus, in this alternative, the entire access port 80 may cleaned andreused or may be single-use. In a further alternative, the access port80 may include a communications interface that may transmit signals fromthe imaging device wirelessly, e.g., using Bluetooth or othercommunications protocols, to allow images to be presented on a remotedisplay.

In an exemplary embodiment, a CMOS, CCD, or other imaging element (notshown) may be provided on the free end 84 b of one of the arms 84 andone or more LEDs or other light sources may be provided on the free end84 b of the other arm 84. Alternatively, separate light sources andimaging elements may be provided on both arms, e.g., to provide multipleimages simultaneously on the display 82. In a further alternative, onlyone arm may be provided, if desired, including one or more light sourcesand/or imaging elements on its free end.

In any of these embodiments, one or more wires may transmit signals fromthe imaging element(s) to the display 82, which may include a processorto process the signals and present the images on a screen of the display82. The imaging element(s) may include a field of view oriented distallybeyond the distal end 76 of the tubular body 72, e.g., to illuminateand/or image an instrument deployed within a region beyond the distalend 76.

The arms 84 are movable between a retracted configuration, e.g., asshown in FIGS. 6A and 6D, which may facilitate introduction into apatient's body, and a deployed configuration, e.g., as shown in FIGS.6B, 6C, and 6E, where the imaging device may be used to acquire imagesduring a procedure. In one embodiment, the arms 84 may be biased to theretracted configuration, but may be directed to the deployedconfiguration when an instrument is inserted into the primary lumen 78a, as described further below. Alternatively, the arms 84 may beactuated (or moved) by a user selectively between the retracted anddeployed configurations, if desired.

For example, with particular reference to FIGS. 6D and 6E, the firstends 84 a of the arms 84 may include ramps or other features 84 c thatextend partially into the primary lumen 78 a. Consequently, when aninstrument is inserted into the lumen 78 a, the instrument may contactthe ramps 84 c, thereby deflecting the arms 84 outwardly to the deployedconfiguration. As can be seen in FIG. 6E, in the deployed configuration,the ramps 84 c may be substantially flush with the wall of the tubularbody 72 such that the ramps 84 c do not interfere with manipulation ofthe instrument. When the instrument is removed, the arms 84 may returnautomatically back towards the retracted configuration. Alternatively,the arms 84 may remain deployed until actuated or until the access port70 is removed, e.g., whereupon the arms may be collapsed inwardly asthey contact tissue along the exit path. In another alternative, acircumferential light source, such as a circular Xenon LED lamp (notshown) may be provided on the distal end of the access port instead ofthe arms.

Turning to FIGS. 7A-7D, an exemplary embodiment of a staple or clip 90is shown that may be delivered using any of the stapler apparatusherein. Generally, the staple 90 includes a base 92, e.g., asubstantially straight segment, from which first and second tines 94, 96extend, e.g., substantially perpendicular to the base 92. The tines 94,96 may be substantially straight terminating in respective tips 95, 97.Thus, for example, the base 92 and tines 94, 96 may define asubstantially rectangular “U” shape, e.g., with rounded transitionsbetween the base 92 and the tines 94, 96. As shown, the first tine 94has a length that is substantially shorter than the second tine 96. Inaddition, the second tine 96 has a length from the base 92 to its tip 97that is longer than the length of the base 92. Consequently, the secondtine 96 may be bent or otherwise deformed towards the first tine 94,e.g., as shown in FIG. 7D.

In the example shown, the staple 90 has a cross section that issubstantially uniform along the length of the staple 90, e.g., along alength of the first tine 94, along the base 92, and along the secondtine 96. For example, the staple may have a substantially rectangular(with or without sharp corners), oblong, or other generally flattenedcross-section, e.g., having a width “w” that is thicker than a thickness“t,” as indicted in FIGS. 7A-7D.

In addition, the first tine 94 includes a notch 98 adjacent its tip 95configured to receive the tip 97 of the second tine 96 when it isdeformed. For example, as shown, the tip 97 of the second tine 97 may bebeveled such that the tip 97 tapers towards the first tine 94, which mayenhance the tip 97 being locked into the notch 98. Alternatively, asshown in FIG. 8A, the tip 97 a of the second tine 96 a may be beveled inthe opposite direction, i.e., away from the first tine 92 a. Inaddition, or alternatively, the staple may include different ridges fordifferent thickness compression.

Optionally, as shown in FIG. 8C, the first tine 94 c may include aplurality of notches 98 c spaced apart from one another along the lengthof the first tine 94 c. Thus, in this embodiment, the tip 97 c of thesecond tine 96 c may be ratcheted sequentially into the notches 98 c,e.g., simply locked into the top notch 98 c or down into one of thenotches further down on the first tine 94 c. Although three notches 98 care shown in FIG. 8C, it will be appreciated that any desired number ofnotches (two or more) may be provided on the first tine 94 c.Alternatively, the first tine may be provided without any notches (notshown), and the stapler actuator may be configured to bend or otherwisedeform the tip of the first tine over the second tine (after the secondtine has been bent).

In another option, shown in FIG. 8B, a radius of the transition betweenthe base 92 b and the second tine 96 e may be increased, e.g., comparedto the staple 90 shown in FIG. 7C, which may reduce the force to bendthe second tine 96 e during use. In yet another option, shown in FIG.8D, the tip 95 d of the first tine 94 d may include a bevel that isoriented towards the second tine 96 d (as opposed to being oriented awayfrom the second tine 96, as in the staple 90 shown in FIG. 7C). In stillanother option, shown in FIG. 8E, a staple 90 e may be provided thatincludes a bump 93 e in the base 92 e, which may be configured toenhance the pinching/closure of the tissues entrapped within thestaples. It will be appreciated that any of these options may beincluded in one or more of the staples included in any of the staplerapparatus described elsewhere herein.

With additional reference to FIGS. 3A-3C, a plurality of staples, suchas staple 90 shown in FIGS. 7A-7D (or any of the alternatives) may beprovided in each of the receptacles 52 in the first jaw 46. With thereceptacles 52 aligned along the axis 26 of the shaft 20, the base 92 ofeach staple 90 may be seated at the bottom of the respective receptaclewith the first tine 94 closer to the distal tip 46 b of the first jaw 46and the second tine 96 closer to the proximal housing 42 (or reverse).Consequently, as the staples are deployed upwardly from the receptacles52, both tines 94, 96 may be driven through the tissue adjacent thecontact surface 46 a of the first jaw 46, and the second tines 96 maythen be received in the respective recesses 54 in the second jaw 48 asthe staples are pushed upward toward the second jaw 48. This action mayfacilitate bending the second tines 96 distally towards the first tines94. Thus, the second tines 96 may be bent or otherwise deformed abovethe tissue towards the tips 93 of the first tines 94 until the tips 97of the second tines 96 are received in the respective notches 98,thereby locking the staples 90 and compressing the captured tissue.

Turning to FIGS. 9-12, another exemplary embodiment of an access port170 is shown that includes an elongate tubular body 172 and a videomodule 180 that may be coupled to the tubular body 172, e.g., to allowintroduction of one or more instruments through the port 170 into asurgical space within a patient's body while acquiring images within thesurgical space, generally similar to other embodiments herein. As shownin FIG. 10, the tubular body 172 includes a proximal end 174, a distalend 176 sized for introduction into a patient's body, and one or morelumens or passages 178 extending between the proximal and distal ends174, 176. For example, the tubular body 172 may include a primary lumen178 a sized to receive one or more instruments therethrough, such as thestapler apparatus 8 shown in FIGS. 13A and 13B and/or describedelsewhere herein. In addition, the tubular body 172 includes one or moresecondary lumens 178 b, e.g., positioned within a sidewall of thetubular body 172 around the primary lumen 178 a. For example, as bestseen in FIGS. 12A and 12B, three secondary lumens 178 b may bepositioned together on one side of the primary lumen 178 a and a fourthsecondary lumen 178 b may be provided on an opposite side of the primarylumen 178 a to acquire two sets of images simultaneously, as describedfurther elsewhere herein. Outlets 179 b of the secondary lumens 178 b atthe distal end 176 may be open or may include a transparent cover,membrane, and the like (not shown) to prevent bodily fluids or othermaterials from entering the secondary lumens 178 b from the distal end176. The tubular body 172 may be substantially rigid or alternatively atleast a portion of the tubular body 172, e.g., a distal portion, may bemalleable or flexible (not shown).

The video module 180 generally includes an annular hub 182 from which aplurality of elongate sleeves, tubes, or other imaging elements 184extend, e.g., provided in an arrangement corresponding to the secondarylumens 178 b in the tubular body 172. The imaging sleeves 184 may besized to be inserted into the secondary lumens 178 b simultaneously fromthe proximal end 174 of the tubular body 172 such that distal tips 184 bthereof are disposed adjacent the distal end 176 of the tubular body172, e.g., extending slightly from the outlets 184 b for acquiringimages beyond the distal end 176.

Optionally, the proximal end 174 of the tubular body 172 and the hub 182may include cooperating connectors (not shown) to removably couple thehub 182 to the tubular body 172, e.g., such that the access port 170 maybe manipulated as a unitary device.

In addition, one or both of the proximal end 174 of the tubular body 172and the hub 182 may include one or more valves or seals (not shown),e.g., to seal the primary lumen 178 a yet facilitate inserting aninstrument into the primary lumen 178 a, e.g., providing a substantiallyfluid-tight seal around the instrument. In this manner, the seal(s) mayprevent insufflation gas or other fluid to escape through the primarylumen 178 a, e.g., when the access port 170 is introduced into apatient's body, as described elsewhere herein.

In addition, a display or other output device 186 may be provided on thehub 182, e.g., to facilitate observing or otherwise monitoring theprocedure using one or more imaging devices on the access port 170. Inone embodiment, the display 186 may be removably mountable on the hub182, which may include one or more connectors or cables (not shown) thatmay be coupled to corresponding connectors on the hub 182.Alternatively, the display 186 may be permanently mounted to the hub182. In a further alternative, a display may be provided separate fromthe access port 170 and images may be transmitted wirelessly or viawired connection from the access port 170, similar to other embodimentsherein.

Each sleeve 184 may include an elongate tubular body, e.g., formed fromstainless steel or other metal, plastic, and/or composite materialincluding a lumen for carrying one or more imaging components. Thesleeves 184 may be substantially rigid or, alternatively, may besufficiently flexible to follow the shape of the lumens 178 b, e.g., ifthe tubular body 172 is malleable or flexible and directed to anonlinear shape.

In an exemplary embodiment, at least one of the imaging sleeves 184 maycarry a CMOS, CCD, or other camera (not shown) on its distal tip 184 bto acquire the images. Alternatively, a lens may be provided on thedistal tip 184 b and a fiberoptic cable or other optical conductor (alsonot shown) may extend through the imaging sleeve 184 to the proximal end184 a, where the conductor may be coupled to a camera to acquire theimages.

Similarly, at least one of the imaging sleeves 184 may carry anillumination source, e.g., an LED or other light source, on its distaltip 184 b for transmitting light beyond the distal end 176 of thetubular body 172. Alternatively, the LED or other light source may beprovided within the hub 180, and an optical conductor may extend fromthe proximal end 184 a of the imaging sleeve 184 to its display tip 184b. In the example shown, the video module 180 includes a pair of sleeves184 on opposite sides of the primary lumen 178 a carrying cameras ondistal tips 184(1), and a pair of sleeves 184 on opposite sides of oneof the camera sleeves carrying an LED or other illumination source onthe distal tips 184(2) (or may carry lenses coupled to cameras or LEDs),e.g., providing a field of view as shown in FIG. 9C. In thisconfiguration, images may be acquired substantially simultaneously fromopposite distal tips 184 b(1) to provide binocular imaging on eitherside of the end effector 40 (as shown in FIG. 13B), with the distal tips184 b(2) providing off-axis illumination to minimize shadows orotherwise enhance illumination within a surgical space.

During use, the imaging elements 184 may be inserted into inlets 175 bfrom the proximal end 174 of the tubular body 172 into the correspondingsecondary lumens 178 b until the distal tips 184 b are positionedadjacent the distal end 176 of the tubular body 172, e.g., extending adesired distance from the outlets 179 b to allow acquisition of images.Optionally, when the imaging elements 184 are fully inserted, connectorson the hub 182 and/or proximal end 174 may engage to secure the videomodule 180 relative to the tubular body 172. The assembled access port170 may then be introduced into a patient's body to allow introductionof one or more instruments to be introduced to perform a surgicalprocedure while acquiring images of the procedure, similar to otherembodiments herein. For example, as shown in FIGS. 13A and 13B, an endeffector 40 of a stapler apparatus 8 may be inserted through the primarylumen 178 a to staple and/or remove tissue, as described elsewhereherein.

Upon completing the procedure, any instruments may be removed from theprimary lumen 178 a, and the port 170 may be removed from the patient'sbody using conventional methods. The video module 180 may be removedfrom the tubular body 172 and then cleaned, sterilized, and/or otherwiseprepared for use again in a subsequent procedure. The tubular body 172may be single-use, and may be discarded after the procedure.Alternatively, the tubular body 172 may also be cleaned, sterilized,and/or otherwise prepared for reuse.

Turning to FIG. 14, another exemplary embodiment of a stapler apparatus208 is shown that includes a video module 280 integrated into a reusableshaft/handle portion 210. Generally, the handle portion 210 includes ashaft 220 extending from a handle 230 including actuation components(not shown), e.g., such that a disposable end effector (not shown) maybe coupled to a distal end 224 of the shaft 220, similar to otherembodiments herein.

Unlike the previous embodiments, a plurality of elongate imaging sleeves284 also extend from the handle portion 210, e.g., from a hub 282 fromwhich the shaft 220 also extends. As shown, the imaging sleeves 284 maybe positioned radially around the shaft 220 and may have a length longerthan the shaft 220 such that distal tips 284 b of the imaging sleeves284 extend distally beyond the distal end 224 of the shaft 220. Thevideo module 280 may also include a display 286 mounted on the hub 282(or elsewhere on the handle portion 210 and/or remote from the apparatus280, as desired) coupled to one or more cameras and/or illuminationsources (not shown) that may be used to acquire images beyond the distaltips 184 b.

An end effector (not shown) may be coupled to the distal end 224 of theshaft 220 generally similar to other embodiments, e.g., to staple,cauterize, and/or remove tissue. In addition, the housing of the endeffector may include a plurality of secondary lumens (also not shown)that may receive the imaging sleeves 284 such that the distal tips 284 bare disposed adjacent jaws of the end effector, e.g., similar to theconfiguration shown in FIG. 13B.

During use, a desired end effector may be received over the imagingsleeves 284 and coupled to the distal end 224 of the shaft. Optionally,a cartridge (not shown) may be loaded into one of the jaws of the endeffector and then the end effector may be introduced into a patient'sbody to perform a surgical or other medical procedure, similar to otherembodiments herein. IN this manner, the video module 280 may be used toacquire images during the procedure. Upon completing the procedure, theapparatus 208 may be removed, the end effector may be removed and,optionally discarded, and the handle portion 210 may be cleaned and/orotherwise prepared for use in another procedure, also similar to otherembodiments herein.

Alternatively, it will be appreciated that other staples or clips may bedelivered using any of the stapler apparatus herein, such as thosedescribed in the provisional application incorporated by referenceherein.

It will be appreciated that elements or components shown with anyembodiment herein are exemplary for the specific embodiment and may beused on or in combination with other embodiments disclosed herein. Inaddition, although the apparatus herein have been described forparticular use during an appendectomy procedure. It will be appreciatedthat the apparatus and methods herein may be used in a variety ofsurgical procedures, e.g., including open, minimally invasive,laparoscopic, and other procedures, where it is desired to staple andremove target tissues, e.g., within a patient's intestine, lungs,vasculature, and other locations.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

1. An apparatus for performing a medical procedure, comprising: a shaftcomprising a proximal end, a distal end sized for introduction into apatient's body, and a longitudinal axis extending between the proximaland distal ends; first and second jaws on the distal end of the shaftthat are movable relative to one another between open and closedpositions, thereby directing first and contact surfaces of the first andsecond jaws away from and towards one another, respectively, the firstjaw carrying one or more staples deployable from the first contactsurface; a Doppler sensor on one of the first or second contactsurfaces; a thermal element disposed on one of the first jaw or secondjaw for delivering thermal energy; and a handle on the proximal end ofthe shaft comprising a first actuator for selectively moving the jawsbetween the open and closed positions, a second actuator for deployingone or more staples from the first jaw into tissue between the first andsecond contact surfaces and toward the second jaw to deform the one ormore staples, and a third actuator for activating the Doppler sensor todetect blood flow in the tissue.
 2. The apparatus of claim 1, whereinthe first and second jaws are carried on an end effector removablycoupled to the distal end of the shaft.
 3. The apparatus of claim 2,further comprising a cartridge removably received in the first jaw, thecartridge carrying the one or more staples.
 4. The apparatus of claim 1,wherein the first jaw is fixed relative to the shaft and the second jawis pivotable relative to the first jaw between the open position toallow tissue to be positioned on the first contact surface, and theclosed position to secure the tissue between the first and secondcontact surfaces.
 5. The apparatus of claim 3, wherein the firstactuator comprises a trigger for directing the second jaw from the openposition to the closed position to secure the tissue between the firstand second contact surfaces and the second actuator comprises a wedgemechanism for driving the one or more staples from the first jaw throughthe tissue and towards the second jaw to staple the tissue.
 6. Theapparatus of claim 5, wherein the first actuator further comprises alocking mechanism for locking the second jaw in the closed position. 7.The apparatus of claim 1, further comprising a processor coupled to theDoppler sensor for receiving signals from the Doppler sensor to identifyblood flow in tissue contacting the Doppler sensor, and an output devicecoupled to the processor for providing an output indicating whetherblood is flowing in the tissue.
 8. The apparatus of claim 1, furthercomprising a cutting element disposed on the distal end, the handlecomprising a fourth actuator for advancing the cutting element betweenthe first and second jaws to sever the stapled tissue.
 9. The apparatusof claim 1, wherein the first jaw carries a cartridge including firstand second sets of staples positioned on opposite sides of the cuttingelement.
 10. The apparatus of claim 9, wherein the first and second setsof staples are positioned in rows aligned with the longitudinal axis,and wherein the cutting element is advanceable from a retracted positionto an advanced position aligned with the longitudinal axis.
 11. Theapparatus of claim 1, wherein the thermal element is disposed on one ofthe first jaw or second jaw generally opposite the Doppler sensor fordelivering thermal energy to the stapled tissue.
 12. The apparatus ofclaim 1, wherein the thermal element comprises an electrode carried onthe first jaw, and wherein a source of electrical energy is coupled tothe thermal element, the handle comprising an actuator for activatingthe source of energy to deliver the electrical energy to the electrodeto deliver thermal energy to the stapled tissue.
 13. The apparatus ofclaim 1, further comprising one or both of a camera and a light sourceon the distal end to facilitate imaging a region within the patient'sbody into which the first and second jaws are introduced.
 14. An endeffector for a stapler apparatus including a shaft comprising a proximalend including a handle, a distal end sized for introduction into apatient's body, and a longitudinal axis extending between the proximaland distal ends, the end effector comprising: one or more connectors forremovably connecting the end effector to the distal end of the shaft;first and second jaws that are movable relative to one another betweenopen and closed positions using a first actuator on the handle, therebydirecting first and contact surfaces of the first and second jaws awayfrom and towards one another, respectively, to engage tissue between thefirst and second contact surfaces; one or more staples carried by thefirst jaw such that actuation of a second actuator on the handle deploysone or more staples from the first jaw into tissue between the first andsecond contact surface towards the second jaw to deform the one or morestaples; and a Doppler sensor on one of the first and second contactsurfaces to detect blood flow in the tissue.
 15. The end effector ofclaim 14, further comprising a cartridge removably received in the firstjaw, the cartridge carrying the one or more staples.
 16. The endeffector of claim 14, wherein the first jaw is fixed relative to theshaft when the cartridge is connected to the distal end of the shaft andthe second jaw is pivotable relative to the first jaw using the firstactuator between the open position to allow tissue to be positioned onthe first contact surface, and the closed position to engage the tissue,the end effector further comprising a wedge mechanism advanceable by thesecond actuator to drive the one or more staples from the first jawthrough the tissue.
 17. The end effector of claim 14, wherein the one ormore staples comprise first and second sets of staples positioned in oneor more rows aligned with the longitudinal axis of the shaft, the endeffector further comprising a cutting element advanceable from aretracted position to an advanced position aligned with the longitudinalaxis to sever the stapled tissue. 18-21. (canceled)
 22. The end effectorof claim 14, further comprising a thermal element disposed on one of thefirst and second jaws for delivering thermal energy to the stapledtissue.
 23. (canceled)
 24. The end effector of claim 14, furthercomprising one or both of a camera and a light source to facilitateimaging a region within the patient's body into which the first andsecond jaws are introduced.
 25. A method for performing a surgicalprocedure within a patient's body, comprising: introducing first andsecond jaws on a distal end of a shaft into a region within thepatient's body; with the jaws in an open position, placing tissue withinthe region between contact surfaces of the first and second jaws;actuating one or both of the first and second jaws to secure tissuebetween the contact surfaces; deploying one or more staples from thefirst jaw through the tissue towards the second jaw to deform the one ormore staples and staple the tissue; activating a Doppler sensor on oneof the contact surfaces to detect blood flow in the stapled tissue; andif blood flow is detected, delivering thermal energy to the stapledtissue to stop blood flow. 26-38. (canceled)